First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment (RAAFT-3)

  • STATUS
    Recruiting
  • End date
    Mar 1, 2025
  • participants needed
    120
  • sponsor
    University of Pennsylvania
Updated on 13 October 2022
electrocardiogram
fibrillation
radiofrequency ablation
amiodarone
catheter ablation
antiarrhythmic drug
propafenone
sotalol
persistent atrial fibrillation
pulmonary vein isolation
dronedarone

Summary

The purpose of this study is to determine if catheter-based atrial fibrillation (AF) ablation is superior to treatment with antiarrhythmic drugs as a first-line therapy for symptomatic persistent AF.

Description

The burden of atrial fibrillation (AF) on Western countries healthcare systems is steadily increasing, with over 2 million Americans and 4 million Europeans affected by this condition. It is by far the most common sustained arrhythmia encountered in clinical practice, with a striking impact on morbidity and mortality. Achieving a definite cure is highly desirable, as this would have profound social and economic implication. In patients with drug-refractory paroxysmal AF, multiple clinical trials have established the superiority of catheter ablation over further antiarrhythmic drug (AAD) therapy for the long-term maintenance of sinus rhythm, to improve quality of life, and reduce hospitalizations. Recent randomized controlled trials have also demonstrated a beneficial role of catheter ablation as a first-line therapy in patients with paroxysmal AF, with significantly better arrhythmia control and improved quality of life compared to AAD therapy. Patients with symptomatic persistent AF represent a more challenging group to treat, given the overall lower success rate of catheter ablation procedures in this group of patients. Pharmacologic rhythm-control strategies are also less effective in persistent AF, with a substantially increased economic burden given the repeat admissions for electrical cardioversions and AAD initiation/titration. In patients with symptomatic persistent AF who have already failed AADs, catheter ablation has been shown superior to further AAD therapy for sinus rhythm restoration in a recent randomized controlled trial. However, the value of an upstream adoption of catheter ablation for the treatment of symptomatic persistent AF (i.e., before a trial with AADs) is unknown. The purpose of the third Radiofrequency Ablation vs Antiarrhythmic Drugs for Atrial Fibrillation Treatment (RAAFT-3) trial is to determine whether catheter ablation is superior to AAD as a first-line therapy in patients with persistent AF who had not been exposed to antiarrhythmic treatment.

Details
Condition Atrial Fibrillation
Treatment Anti Arrhythmics, Pulmonary Vein Isolation performed by Radio Frequency Catheter Ablation
Clinical Study IdentifierNCT04037397
SponsorUniversity of Pennsylvania
Last Modified on13 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Eligible patients have a history of persistent AF with at least 2 episodes in the 9 months
prior to enrollment. Persistent AF is defined according to 2014 AHA/ACC/HRS guidelines as
continuous AF that is sustained for more than 7 days.Patients are enrolled if they are
Older than 18
Symptomatic with persistent AF
Experienced at least one AF episode that was documented by surface ECG, 6 months
before randomization

Exclusion Criteria

Documented LVEF <40%
Documented left atrial diameter >/=6cm
Moderate to severe LVH (LV wall thickness >1.5cm)
Documented severe valvular disease (aortic stenosis, mitral regurgitation, tricuspid
regurgitation or presence of mechanical cardiac valves), active coronary artery
disease (defined as the presence of >70% stenosis of coronary arteries or
documentation of active myocardial ischemia), recent (within 6 months) CABG
Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid
Current enrollment in another investigational drug or device study
hormone replacement therapy are acceptable
Absolute contra-indication to the use of heparin and or oral anticoagulation
Contraindication for the use of all antiarrhythmic drugs including sotalol
dofetilide, amiodarone and 1C antiarrhythmic drugs (liver enzymes and serum creatinine
that are outside the upper normal lab values, e.g. > 3 times ULN with 2 abnormal lab
values). [Note: Participants will not be excluded if they are able to take any single
or combination of drugs without contraindications]
Women with a positive pregnancy test
Previous left heart ablation procedure, either by surgery or by percutaneous catheter
Evidence of active cardiac or systemic infection
for atrial fibrillation
Medical condition limiting expected survival to less than one year
Presence of any other condition that the investigator feels would be problematic or
would restrict or limit the participation of the Patient for the entire study period
Increase risk of bleeding, current peptic ulceration, proliferative diabetic
retinopathy, history of severe systemic bleeding, or other history of bleeding
diathesis or coagulopathy
Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive
disease (COPD)
Documented intra-atrial thrombus, tumor, or another abnormality, which precludes left
atrial catheter ablation
Previous use of an antiarrhythmic drug, including amiodarone, propafenone, flecainide
sotalol, quinidine, dofetilide, dronedarone (see below for specifications
Antiarrhythmic Drug Group)
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